[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629763":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":49,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"tumor margin skin tattooing before neo-adjuvant chemotherapy in patients with breast cancer","EXPERIMENTAL","Patients with breast cancer and axillary lymph node metastasis presenting with T1 or T2 stage disease will undergo localization of the primary tumor site using skin tattooing performed in the supine position with the arms abducted at a right angle. In cases of deep-seated or highly mobile tumors, additional localization will be achieved by placement of radiopaque clips under ultrasonographic guidance.\n\nFollowing tumor localization, patients will receive neoadjuvant chemotherapy, and treatment response will be systematically monitored. The feasibility of breast-conserving surgery in this cohort will be evaluated, and any technical challenges encountered during the procedure will be documented. The primary outcome measures will include achievement of negative surgical margins and avoidance of mastectomy.",[13],"Procedure: Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study","Eligible patients with biopsy-proven breast cancer and axillary lymph node metastasis presenting with clinical T1-T2 disease will undergo localization of the primary tumor prior to initiation of neoadjuvant chemotherapy. The procedure will be performed with the patient in the supine position and the ipsilateral arm abducted to 90°, simulating the surgical position. Clinically palpable tumor margins will be identified and marked on the overlying skin using sterile permanent tattoo ink to delineate the pretreatment tumor boundaries. In patients with deep, poorly palpable, or mobile tumors, additional localization will be achieved by placement of radiopaque clips within the tumor under ultrasonographic guidance. Following localization, patients will receive standard neoadjuvant chemotherapy according to institutional protocols. Treatment response will be monitored clinically and radiologically, and the tattoo markings and\u002For clips will guide surgical planning for breast-conserving surgery",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Mithilesh K Sinha, MS","CONTACT","+919438884252","surg_mithilesh@aiimsbhubaneswar.edu.in",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Banothu Raju, MBBS","+917993575975","banothu905@gmail.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"AIIMS Bhubaneswar","RECRUITING","Bhubaneswar","Odisha","751019","India","IN",{"type":41,"coordinates":42},"Point",[43,44],85.83385,20.27241,{"lat":44,"lon":43},[47,48],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Mithilesh Kumar sinha","Professor","100629763","tumor-margin-skin-tattooing-before-neo-adjuvant-chemotherapy-in-patients-with-breast-cancer-100629763",false,"NCT07478900","Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer","Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study","TUMS","Inclusion Criteria:\n\nFemale patients aged 18-75 years\n\nHistologically confirmed Breast Cancer on biopsy\n\nPatients with T2 or T3 breast tumors planned for Neoadjuvant Chemotherapy\n\nPresence of a clinically palpable primary breast tumor suitable for localization\n\nPatients who are candidates for Breast-Conserving Surgery following neoadjuvant therapy\n\nAbility and willingness to provide written informed consent\n\nExclusion Criteria:\n\nKnown allergy or hypersensitivity to tattooing materials used for tumor localization\n\nEarly-stage Breast Cancer not requiring Neoadjuvant Chemotherapy\n\nDiagnosis of Inflammatory Breast Cancer\n\nT3 tumors in patients with small breast size or T4 breast cancer\n\nPatients unwilling to undergo Breast-Conserving Surgery\n\nDiffuse microcalcifications of the breast parenchyma on Mammography\n\nDuctal Carcinoma In Situ\n\nMale Breast Cancer\n\nMulticentric or multifocal breast cancers\n\nTumor location that precludes breast-conserving surgery\n\nRecurrent Breast Cancer","FEMALE","18 Years","75 Years",{"count":65,"type":66},30,"ESTIMATED","INTERVENTIONAL",[69],"NA","Study Description\n\nThis prospective cohort study evaluates the feasibility and effectiveness of pre-neoadjuvant tumor localization using skin tattooing, with or without radiopaque clips, in patients with biopsy-proven T2-T3 breast cancer and axillary lymph node metastasis. Eligible patients will undergo tumor localization in the supine position with the ipsilateral arm abducted to 90°. Palpable tumor margins will be marked with sterile tattoo ink, and deep or mobile tumors will receive additional localization with ultrasonography-guided radiopaque clips. Following localization, patients will receive standard neoadjuvant chemotherapy. Tumor response will be monitored clinically and radiologically. Post-therapy, the tattoo markings and\u002For clips will guide breast-conserving surgery. Primary outcomes include feasibility of breast conservation, achievement of negative margins (R0 resection), and avoidance of mastectomy, while intraoperative technical challenges will also be documented.",[72,73,74],"Breast Cancer (Locally Advanced or Metastatic)","Tattoo Skin Markers","Neoadjuvant Chemoimmunotherapy","2026-03-14",{"date":77,"type":78},"2026-03-18","ACTUAL",{"date":80,"type":78},"2025-09-10",{"date":82,"type":66},"2028-02-09",{"name":5,"class":6},1]